News (Updated February 4,
2007)
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Thursday February 1, 5:36 AM
By Maggie Fox, Health and Science Editor
WASHINGTON, Jan 31 (Reuters) - Trials of a new product designed to help women protect themselves from the AIDS virus were halted on Wednesday after women using it became infected at a higher rate than women not using it, researchers said.
Toronto, Canada-based Polydex Pharmaceuticals said the gel, known as a microbicide, apparently made women more vulnerable to the virus, not less vulnerable, as intended.
Shares of the company plunged as much as 60 percent before closing down nearly 55 percent at $3 a share.
The microbicide, developed under the brand name Ushercell, is a cotton-based compound that had been tested in more than 500 women without any indication it raised the risk of HIV infection.
It was being tested in advanced trials in 1,333 women in South Africa, Benin, Uganda and India.
A second group testing the same compound stopped its trials, too, out of concern for the women, although there was no suggestion the women in the second trial were becoming infected at a higher-than-expected rate.
"It was our hope that this product would have helped women in protecting themselves from HIV," Dr. Lut Van Damme, who was leading the trial of the Polydex product, said in a statement.
"While the findings are unexpected and disappointing, we will learn scientifically important information from this trial that will inform future HIV prevention research."
It is the second spectacular failure of a microbicide -- a gel or a cream designed for women to use vaginally to prevent infection with HIV. Trials of the spermicide nonoxynol-9 were stopped after it was found to raise the risk of HIV infection.
The World Health Organization and the U.N. AIDS agency UNAIDS, which were helping coordinate the trial, said it was not clear why the product did not work.
"Cellulose sulfate was one of four compounds being evaluated in large-scale studies of effectiveness among women at high risk of HIV infection," WHO and UNAIDS said in a joint statement.
Three other products are also in advanced trials, they said, including products based on a seaweed derivative called carrageenan.
Jeff Spieler of the U.S. Agency for International Development, which was also sponsoring the trial, said the product had appeared safe in earlier trials with fewer women.
"I am also hopeful that one or more of the other microbicide candidates now in development will be shown to be safe and effective in helping to prevent HIV infection along with other behavioral interventions," Spieler said in a statement.
Family Health International said it was halting its trial of the same product in 1,700 women in Nigeria. Women in both trials who become infected with HIV will be given drugs to control it, the researchers said.
WHO estimates that half of the 39 million people infected with the human immunodeficiency virus today are women, and HIV is mostly transmitted through sexual intercourse between a man and a woman.
There is no cure for HIV and no vaccine against it. Condoms can prevent infection but women are often powerless to demand their use.
Fri Feb 2, 8:42 PM ET
A hard-to-treat strain of the virus that causes AIDS has been found in four gay men in King County, and authorities fear it could spread to more.
There is no evidence that the troublesome strain of HIV is spreading rapidly, but its appearance underscores the need for renewed emphasis on safe sex practices, officials in the Seattle-King County public health department said Thursday.
"There may be more cases we don't know about," said Dr. Bob Wood, the agency's HIV-AIDS program director.
"We are still working to learn more about these individuals and the virus they have contracted," said Dorothy F. Teeter, interim director of the department. "We are concerned for these individuals and their partners and are continuing our investigation."
The same genetic strain of HIV was found over a 15-month period in all four men, methamphetamine users who each had multiple partners, but none is known to have had sex with any of other three, officials said.
"That's highly unusual," said Dr. Peter Shalit, who treats HIV-AIDS patients and directs HIV-AIDS research at Swedish Medical Center.
One possibility is that there is a new strain of multi-drug-resistant HIV that is spread more easily than previous drug-resistant strains, "definitely a scary prospect," Shalit said.
"There's no evidence that this has spread outside of King County," said Dr. Patrick Sullivan, chief of the behavioral and clinical surveillance branch at the Atlanta-based Centers for Disease Control and Prevention.
But the center also hasn't compared this strain with ones outside of King County because the center studies disease from a population, not an individual, perspective, he said Friday in a telephone interview.
One man in New York, diagnosed with HIV in December 2004, was found to have a multi-drug-resistant type of HIV and he too had multiple, anonymous sexual partners, a history of methamphetamine use and had sex with men, according to the CDC.
Nationally, 2 percent to 3 percent of the HIV strains that people are infected with may be resistant to two to three classes of drugs, Sullivan said.
While at least 100 King County residents die of AIDS annually, there is evidence of declining condom use and other safe-sex practices among gay drug users especially, said Wood, who is gay and has medically managed his own HIV infection for more than 20 years.
"There's a lot of complacency," he said. "People need to know that some of these new infections may be impossible to treat."
Seattle was among the first metropolitan areas in the country to begin a surveillance program for multi-drug-resistant HIV in 2003. Since then, doctors and other health care providers have been asked to test routinely for drug resistance in anyone who is HIV-positive and to report any indication of multi-drug-resistant strains.
Before Thursday, health officials had identified 12 cases of multi-drug-resistant HIV in the county, none as resistant to anti-viral drugs as the most recent four.
None of the four men has experienced any symptoms, Wood said, but experts fear that drug-resistant HIV could progress to AIDS much faster than typical HIV.
In addition, Dr. Robert D. Harrington, director of a Harborview Medical Center clinic for HIV patients, said treatment for those who are resistant to several types of drugs could cost more than twice as much as the $15,000 a year that is needed for typical HIV.
Thu Feb 1, 10:44 PM ET
Heavy alcohol use increases mortality with hepatitis C virus (HCV) to a greater extent in women than in men, according to a report.
"Previous studies indicated that alcohol use is a risk factor for HCV disease progression, but they seldom examined the effect on women and men separately," lead author Dr. Chiung Chen, from CSR, Inc., Arlington, Virginia, said in a statement. "Even fewer studies were able to examine the effect of alcohol on HCV mortality. Our study provides empirical evidence to fill the gap."
Chen and colleagues analyzed 132,468 deaths due to HCV and/or heavy alcohol use entered in National Center for Health Statistics databases between 2000 and 2002.
Female hepatitis C patients who were not heavy drinkers died at an average age of 61.0 years, while those who drank died at 49.1 years.
By contrast, heavy drinking had less effect on lifespan in men, lowering the average age of death with hepatitis C from 55.1 to 50.0 years.
The findings emphasize that heavy drinking is a key factor that influences hepatitis C mortality, the researchers state. More importantly, the study provides the first evidence of a gender difference in alcohol intake-related hepatitis C mortality.
Further studies are warranted to determine if similar differences in HCV mortality are seen across racial/ethnic group and to investigate the possible interactions with HIV coinfection, the researchers conclude.
SOURCE: Alcoholism: Clinical and Experimental Research, February 2007.
Mon Jan 29, 2007 4:51 PM ET
By Maggie Fox, Health and Science Editor
WASHINGTON (Reuters) - Dementia caused by the AIDS virus may be far more common in Africa than previously believed, making it one of the leading causes of dementia in the world, researchers reported on Monday.
Alzheimer's disease and strokes are currently the most common causes of dementia.
But researchers found AIDS-related dementia in 31 percent of HIV patients in Uganda -- an alarmingly high rate.
"If the rate we saw in our study translates across sub-Saharan Africa, we're looking at more than 8 million people in this region with HIV dementia," said Dr. Ned Sacktor, a neurologist at Johns Hopkins University in Baltimore who worked on the study.
"It's obvious if you just look at the numbers -- 27 million people infected in Africa. If anywhere close to 30 percent of those have dementia ... certainly it would be among the more common forms of dementia," Sacktor added in a telephone interview.
"Clearly, large-scale testing would have to be conducted before we know the global reach of HIV dementia, but this study sends a clear message that it exists in high proportions in sub-Saharan Africa and is an under-recognized condition that needs to be studied and treated."
Doctors know that the AIDS virus can cause dementia, probably by destroying brain cells. AIDS drug combinations greatly reduce this rate but only 20 percent of people infected with HIV in the world get the drugs.
The dementia hits people at a much younger age than Alzheimer's usually does, and has even been seen in children, Sacktor said.
"They have memory problems. They are very slow in responding to questions. They have motor coordination problems. They have gait difficulties. They can have mood disturbances such as depression. They can have apathy, very little interest in doing things."
Writing in the journal Neurology, Sacktor and colleagues said they studied 178 people in Uganda, from September 2003 to January 2004. They said 100 were normal, healthy adults and 78 had the AIDS virus.
About 25 of the HIV patients had dementia -- 31 percent of the total. None of the people without HIV had it, Sacktor said.
Giving people the HIV drug combinations known as highly active antiretroviral therapy can reverse the damage, Sacktor said. Without it, the numbers of patients could grow, the researchers said.
"These individuals with HIV dementia would have higher rates of unemployment and a decreased ability to perform their activities of daily living," they wrote.
Alzheimer's is the leading cause of dementia globally, affecting 18 million people according to the World Health Organization, and 5 million people in the United States alone. There is no cure for Alzheimer's, which becomes far more common as people age.
Tue Jan 30, 9:00 AM
By Andrew Quinn
JOHANNESBURG (Reuters) - South Africa's AIDS epidemic, often regarded by health workers as a disease of the poor, is in fact spreading quickly among the country's richest and best educated people, researchers said on Tuesday.
The study by the Markinor polling firm and the University of South Africa (UNISA) showed a rapid increase in HIV infections in professional people and those with full-time employment -- both key to South Africa's hopes to spur economic development.
"The high risk group is growing, it is getting older and it is getting richer," said Carel van Aardt, director of UNISA's Bureau of Market Research. "This could represent a whole new wave of the epidemic."
The study challenges widespread assumptions about South Africa's HIV/AIDS crisis, which is often described as a disease of the rural poor who lack access to information, treatment and basic health services.
South Africa now has some 5.5 million HIV-positive people out of a total population of some 45 million, giving it an estimated overall prevalence rate of about 11 percent and one of the worst AIDS caseloads in the world.
The new study examined some 3,500 South Africans between the years of 2002-2005, a poll engineered to reflect the country's racial and economic demographics.
Overall, the study identified young people below the age of 30 as being at greatest risk for HIV, as most previous research has done. But it also found infections rising at alarming rates in the rich and better educated -- groups not previously singled out as being at risk.
"We are on the eve of a very scary reality unless we start making some changes," said Tracy Hammond, Markinor's project manager for the study.
UP THE SOCIAL LADDER
Researchers said there were many possible factors behind the spread of HIV among upper levels of society, among them confused government messages about HIV/AIDS, greater disposable income and leisure, and general apathy about safe sex practices.
But whatever the reason, AIDS is certainly climbing the social ladder for both black and white South Africans.
Among South Africa's professionals, for instance, the study found a 34 percent jump in estimated HIV prevalence, rising to 8.3 percent in 2004 from 6.2 percent in 2002.
People with full-time jobs -- who in South Africa account for only about half the working population -- saw estimated HIV-prevalence rise to 19.2 percent in 2005 from 14.4. percent in 2002, an increase of 36 percent.
Unemployed people, while seeing a bigger percentage jump in HIV prevalence, remained lower in terms of actual prevalence rates with just 18.4 percent estimated infected in 2005 compared with 11 percent in 2002.
In a further piece of alarming news, the study said HIV infection was growing most quickly in those aged between 30-34, threatening people just as their careers take off.
Overall, the richest third of South Africa's population still has a lower estimated HIV-prevalence than the poorest third, at 8.5 percent compared to 23.4 percent.
But the study said new infections were increasing most rapidly in this demographic, rising by 39 percent between 2002-2005 against only a 14 percent increase for their poorest compatriots.
"This time it is not the employees, it is the employers. It is not the people without bank accounts, it is the people who make investments," Markinor's Hammond said. "If we thought the AIDS epidemic was having bad economic effects already, this could take us to the crisis point."
Friday February 2, 9:35 am ET
The company plans on testing its lead Bioral candidate, an oral version of Amphotericin B, which is an antifungicidal used to treat infections including esophageal candidiasis, an infection prevalent in HIV patients and cancer patients receiving chemotherapy.
Bioral technology is aimed at turning drugs available only by injection into orally administered doses. It uses cochleates, or naturally occurring substances designed to encapsulate, protect and deliver certain drug molecules.
BioDelivery Sciences did not outline its timeline for the beginning of Phase I clinical trials.
Sat Feb 3, 8:27 AM ET
Health Minister Kamran Baqeri Lankarani has announced that Iran's scientists have produced a herbal medicine that boosts the human's body immunity system against the HIV/AIDS virus.
"The herbal-based medication, called IMOD, serves to control the AIDS virus and increases the body's immunity," Baqeri Lankarani was quoted as saying by the official news agency IRNA.
"It is not a medication to kill the virus, it rather can be used besides other anti-retroviral drugs," Baqeri Lankarani said on state radio.
The drug, made after five years of research, has been tested on 200 patients, IRNA said, adding that it is considered the fifth generation of medications helping control the HIV/AIDS virus.
"This is a substance good for both AIDS patients and those who carry the virus without showing the symptoms," the director of the project, Mohammad Farhadi, told state television.
Farhadi said the medication will now be tested on some 3,000 to 5,000 Iranian patients in the next year to monitor its efficacy.
Health Minister Baqeri Lankarani said that the number of HIV/AIDS cases in Iran stands at around 14,000 while 1,700 people have died of the disease.
Last June, Iranian officials warned about the rapid spread of HIV/AIDS infections in the country due to a surge in intravenous drug usage.
"If no action is taken against the spread of this disease as quickly as possible, the number of those infected will reach 100,000 by the end of the next Iranian year (March 2008)," said Iran's deputy health minister, Moayed Alavian.
Iran is believed to have at least two million regular drug users -- and possibly as many as 3.5 million. Alavian said addiction is growing by around eight percent a year.
Intravenous drug use is believed to be the main cause of HIV/AIDS infection at 62.3 percent, followed by "unknown causes" at 27.9 percent and sexual contact at 7.4 percent.